drugset / Trial / NCT04388826

COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111

NCT04388826 ↗

Phase 2 Completed 39 enrolled Veru Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).

Timeline

Start
2020-06-18
Primary completion
2020-12-18
Completion
2021-08-13

Outcome

Met primary endpoint

release “Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction in death or respiratory failure at Day 29” verupharma.com ↗

release “For the primary endpoint in a modified intent-to-treat (MITT) population, VERU-111 treatment compared to placebo had a statistically significant” verupharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sabizabulin Small molecule 18 mg Oral